Assessing the Stability and Safety of Procedure during Endoscopic Submucosal Dissection According to Sedation Methods: A Randomized Trial

<div><p>Background</p><p>Although endoscopic submucosal dissection (ESD) is routinely performed under sedation, the difference in ESD performance according to sedation method is not well known. This study attempted to prospectively assess and compare the satisfaction of the endoscopists and patient stability during ESD between two sedation methods.</p><p>Methods</p><p>One hundred and fifty-four adult patients scheduled for ESD were sedated by either the IMIE (intermittent midazolam/propofol injection by endoscopist) or CPIA (continuous propofol infusion by anesthesiologist) method. The primary endpoint of this study was to compare the level of satisfaction of the endoscopists between the two groups. The secondary endpoints included level of satisfaction of the patients, patient’s pain scores, events interfering with the procedure, incidence of unintended deep sedation, hemodynamic and respiratory events, and ESD outcomes and complications.</p><p>Results</p><p>Level of satisfaction of the endoscopists was significantly higher in the CPIA Group compared to the IMIE group (IMIE vs. CPIA; high satisfaction score; 63.2% vs. 87.2%, <i>P</i>=0.001). The incidence of unintended deep sedation was significantly higher in the IMIE Group compared to the CPIA Group (IMIE vs. CPIA; 17.1% vs. 5.1%, <i>P</i>=0.018) as well as the number of patients showing spontaneous movement or those requiring physical restraint (IMIE vs. CPIA; spontaneous movement; 60.5% vs. 42.3%, <i>P</i>=0.024, physical restraint; 27.6% vs. 10.3%, <i>P</i>=0.006, respectively). In contrast, level of satisfaction of the patients were found to be significantly higher in the IMIE Group (IMIE vs. CPIA; high satisfaction score; 85.5% vs. 67.9%, <i>P</i>=0.027). Pain scores of the patients, hemodynamic and respiratory events, and ESD outcomes and complications were not different between the two groups.</p><p>Conclusion</p><p>Continuous propofol and remifentanil infusion by an anesthesiologist during ESD can increase the satisfaction levels of the endoscopists by providing a more stable state of sedation.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="https://www.clinicaltrial.gov/ct2/show/NCT01806753?term=nct01806753&rank=1" target="_blank">NCT01806753</a></p></div

Lesion characteristics and outcomes of endoscopic submucosal dissection.

<p>^aThe percentage of this variable was calculated based on the number of early gastric cancer lesions.</p><p>^bThe percentage of this variable was calculated based on the number of patients.</p><p>IMIE, intermittent midazolam/propofol injection by endoscopist; CPIA, continuous propofol infusion by anesthesiologist; ESD, endoscopic submucosal dissection; N/A, not applicable.</p><p>Lesion characteristics and outcomes of endoscopic submucosal dissection.</p

Modified Observer’s Assessment of Alertness/Sedation Scale [18].

<p>Modified Observer’s Assessment of Alertness/Sedation Scale [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0120529#pone.0120529.ref018" target="_blank">18</a>].</p

Adverse events.

<p>IMIE, intermittent midazolam/propofol injection by endoscopist; CPIA, continuous propofol infusion by anesthesiologist; MOAA/S, modified observer assessment of alertness/sedation.</p><p>Adverse events.</p

Sedation-related data, speed of recovery and satisfaction scores.

<p>Values are mean ± SD or n (%) of patients.</p><p>IMIE, intermittent midazolam/propofol injection by endoscopist; CPIA, continuous propofol infusion by anesthesiologist; N/A, not applicable.</p><p>Sedation-related data, speed of recovery and satisfaction scores.</p

Demographic data.

<p>Values are mean ± SD or n (%) of patients.</p><p>^aAntiplatelet agents or anticoagulants include aspirin, non-steroidal anti-inflammatory drugs and warfarin. The aforementioned drugs were discontinued in all patients prior to endoscopic submucosal dissection. ‘Use of antiplatelet agents or anticoagulants’ indicates the number of patients who took these medications.</p><p>IMIE, intermittent midazolam/propofol injection by endoscopist; CPIA, continuous propofol infusion by anesthesiologist; ASA, American Society of Anesthesiologists.</p><p>Demographic data.</p

Associate factor for affecting high satisfaction score of endoscopist.

<p>IMIE, intermittent midazolam/propofol injection by endoscopist; CPIA, continuous propofol infusion by anesthesiologist; OR, odds ratio; CI, confidence interval; N/A, not applicable.</p><p>Associate factor for affecting high satisfaction score of endoscopist.</p

CONSORT flow chart of patient sample selection.

<p>CONSORT flow chart of patient sample selection.</p

Clinical risk stratification model for advanced colorectal neoplasia in persons with negative fecal immunochemical test results

<div><p>Objectives</p><p>The fecal immunochemical test (FIT) has low sensitivity for detecting advanced colorectal neoplasia (ACRN); thus, a considerable portion of FIT-negative persons may have ACRN. We aimed to develop a risk-scoring model for predicting ACRN in FIT-negative persons.</p><p>Materials and methods</p><p>We reviewed the records of participants aged ≥40 years who underwent a colonoscopy and FIT during a health check-up. We developed a risk-scoring model for predicting ACRN in FIT-negative persons.</p><p>Results</p><p>Of 11,873 FIT-negative participants, 255 (2.1%) had ACRN. On the basis of the multivariable logistic regression model, point scores were assigned as follows among FIT-negative persons: age (per year from 40 years old), 1 point; current smoker, 10 points; overweight, 5 points; obese, 7 points; hypertension, 6 points; old cerebrovascular attack (CVA), 15 points. Although the proportion of ACRN in FIT-negative persons increased as risk scores increased (from 0.6% in the group with 0–4 points to 8.1% in the group with 35–39 points), it was significantly lower than that in FIT-positive persons (14.9%). However, there was no statistical difference between the proportion of ACRN in FIT-negative persons with ≥40 points and in FIT-positive persons (10.5% vs. 14.9%, <i>P</i> = 0.321).</p><p>Conclusions</p><p>FIT-negative persons may need to undergo screening colonoscopy if they clinically have a high risk of ACRN. The scoring model based on age, smoking habits, overweight or obesity, hypertension, and old CVA may be useful in selecting and prioritizing FIT-negative persons for screening colonoscopy.</p></div

Point assignments for predicting advanced colorectal neoplasia in persons with negative fecal immunochemical test results.

<p>Point assignments for predicting advanced colorectal neoplasia in persons with negative fecal immunochemical test results.</p